Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00619892
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016584', 'term': 'Panic Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'agoddard@fresno.ucsf.edu', 'phone': '559-499-6580', 'title': 'Andrew Goddard, M.D.', 'organization': 'UCSF Fresno'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Quietapine Group', 'description': 'quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.', 'otherNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.', 'otherNumAtRisk': 13, 'otherNumAffected': 5, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Derealization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shakiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine SR', 'description': 'quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the end of 8 weeks of treatment', 'description': 'Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy \\& the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, \\& 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).\n\nquetiapine XR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).\n\nplacebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.'}], 'classes': [{'title': 'Decrease in HAM-D scores', 'categories': [{'measurements': [{'value': '5.0', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in HAM-A scores', 'categories': [{'measurements': [{'value': '6.8', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Increase in PSQI sleep quality scores', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Comparing baseline and the end of 8 weeks of treatment', 'description': 'Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM-A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quetiapine SR', 'description': 'quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Intercurrent illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Quetiapine', 'description': 'Quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '35.5', 'spread': '16.8', 'groupId': 'BG001'}, {'value': '35.5', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Panic Disorder Severity Scale', 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '13.7', 'spread': '3', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '3.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Possible range 0-28 (7 questions, each scored from 0 to 4, with higher numbers indicating more severe panic symptoms).\n\nMean (Standard Deviation)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression-Severity Scale (CGI-S)', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '4.4', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, where 1 =normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hamilton Anxiety Rating Scale (HAM-A)', 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '17', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '19.1', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Hamilton Anxiety Rating Scale (HAM-A) is a questionnaire used by clinicians to rate the severity of a patient's anxiety. The scale consists of 14 items designed to assess the severity of a patient's anxiety, each of which is rated on a scale of 0 to 4, with 4 being the most severe. Total scores can range from 0 to 56.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hamilton Depression Rating Scale (HAM-D)', 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '11.5', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '13.1', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The HAM-D is a questionnaire with 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale. The total scores indicate levels of depression, where 0-7= normal; 8-13 = mild depression; 14-18 = moderate depression; 19-22 = severe depression; and 23 or greater = very severe depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pittsburgh Sleep Quality Index (PSQI) sleep hours', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '6.7', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '6.5', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The PSQI sleep hours subscale is a self-reported measure of the number of hours patients slept per night over the past month.', 'unitOfMeasure': 'hours slept per night', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pittsburgh Sleep Quality Index (PSQI) sleep quality', 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PSQI sleep quality subscale is a self-reported measure of the patient's sleep quality over the past month, with a possible range of 0-3, where 0 = very good; 1 = fairly good; 2= fairly bad; and 3 = very bad.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-15', 'studyFirstSubmitDate': '2008-02-11', 'resultsFirstSubmitDate': '2015-07-27', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-15', 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores', 'timeFrame': 'Baseline and the end of 8 weeks of treatment', 'description': 'Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).', 'timeFrame': 'Comparing baseline and the end of 8 weeks of treatment', 'description': 'Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM-A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SSRI Resistant', 'Seroquel SR', 'Seroquel XR', 'Panic Disorder', 'Comorbid Panic Disorder', 'Quetiapine SR', 'Quetiapine XR'], 'conditions': ['Panic Disorder']}, 'referencesModule': {'references': [{'pmid': '26379759', 'type': 'DERIVED', 'citation': 'Goddard AW, Mahmud W, Medlock C, Shin YW, Shekhar A. A controlled trial of quetiapine XR coadministration treatment of SSRI-resistant panic disorder. Ann Gen Psychiatry. 2015 Sep 15;14:26. doi: 10.1186/s12991-015-0064-0. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus placebo.', 'detailedDescription': 'This was a single-site, double-blind, placebo-controlled (PLAC), randomized, parallel group (2 groups), 8-week, quetiapine extended release (XR) coadministration trial. SSRI resistance was determined either historically or prospectively. Patients were randomized if they remained moderately ill (CGI-S score ≥ 4). Change in the PDSS scale total score was the primary efficacy outcome measure. Responders were identified as those with a ≥50 % decrease from their baseline PDSS score. In the early weeks of therapy, XR was flexibly and gradually titrated from 50 to 400 mg/day.\n\nConclusions: This proof-of-concept RCT did not support the efficacy of this treatment strategy for SSRI-resistant PD. Quetiapine XR was generally well-tolerated. Important limitations were the small sample size, and the relatively low average dose of quetiapine XR used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of written informed consent\n* Diagnosis of Panic Disorder by DSM-IV TR and confirmed by MINI plus interview\n* Females and males ages 18-65 years old\n* Female patients of childbearing potential must by using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment\n* Able to understand and comply with the requirements of the study\n* Have a CGI illness severity score = or \\> 4\n* Patients with comorbid major depression, dysthymia or other anxiety problems are eligible to participate as well.\n\nExclusion criteria:\n\n* Pregnancy or lactation\n* Any DSM-IV TR Axis I disorder not mentioned in the inclusion requirements\n* Suicidal or danger to self or others\n* Known intolerance to quetiapine fumarate or intolerance to SSRI therapy\n* Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to : ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir\n* Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to : phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids\n* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization\n* Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria\n* Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV TR criteria within 4 weeks prior to enrollment\n* Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment\n* Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension) as judged by the investigator\n* Involvement in the planning and conduct of the study\n* Previous enrollment or randomization of treatment in the present study\n* Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements\n* A patient with a diagnosis of Type I or Type II Diabetes Mellitus (DM)\n* An absolute neutrophil count (ANC) of 1.5 x 109 per liter\n* A lifetime history of a pre-existing CNS/neurological disorder e.g. epilepsy, TBI, brain tumor\n* Patient with severe personality disorders\n* Patients who have started a new course of psychotherapy (CBT, supportive, insight-oriented) within 1 month of the screening visit\n* Patients unwilling to refrain from participation in psychotherapy during the 9-week period of the study."}, 'identificationModule': {'nctId': 'NCT00619892', 'briefTitle': 'A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'An 8-week, Randomized, Double-Blind, Placebo-Controlled Trial of Seroquel SR Co-administration for SSRI-Resistant, Comorbid Panic Disorder', 'orgStudyIdInfo': {'id': '0703-22'}, 'secondaryIdInfos': [{'id': 'IRUSQUET0445', 'type': 'OTHER_GRANT', 'domain': 'Astra Zeneca'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quetiapine XR', 'description': 'Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy \\& the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, \\& 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).', 'interventionNames': ['Drug: quetiapine XR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'quetiapine XR', 'type': 'DRUG', 'otherNames': ['Seroquel SR', 'Seroquel XR'], 'description': 'Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.', 'armGroupLabels': ['Quetiapine XR']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Astra Zeneca placebo'], 'description': 'Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'University Hospital Outpatient Center, Psychiatry', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Andrew W. Goddard, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}